1. Field of the Invention
The present invention relates to the field of orthotics. More specifically it relates to an orthosis applied to the spine to help prevent progressive kyphosis.
2. Description of the Related Art
As one of skill in the art of orthopedic spine surgery, or orthopedics, will recognize, patients, especially older patients in their late 60s, 70s, 80s and older, may have developed painful progressive kyphosis, and have become dependent on assistive devices for ambulation such as, for example, a cane, Canadian crutches, a walker or a wheelchair. Many of these patients have developed this deformity from a myriad of different conditions, some of which are: poor posture, compression fractures secondary to osteoporosis or other metabolic bone diseases (e.g., osteomalacia, traumatic burst fractures or compression fractures), iatrogenic topping off phenomenon (in which adjacent cephalad segments to a fusion have developed, and collapsed into kyphosis), ligament injuries leading to instability and progressive kyphosis, and degenerative disk disease leading to thoracolumbar kyphoscoliosis and/or flat back syndrome, etc. It is the job of an orthopedic spine surgeon to become aware of this condition and try to intervene. Such methods of intervention have included: a reminder by the spouse or friend to improve posture, intervention with physical therapy for postural strengthening exercises, intermittent brace immobilization, (e.g., a Jewett orthosis, a TLSO (thoracolumbar spinal orthosis), a Cash orthosis, or lumbosacral corsets, etc), involvement in work out classes (e.g., weight lifting, yoga, Pilates, tae chi, marshal arts, etc.), but all of these act only as temporary measures. The kyphosis usually continues to occur leading to increased deformity, difficulty ambulating and the need many times for an assistive device and use of medications and/or surgery to correct the deformity.
Braces that have been used in the thoracolumbar sacral region tend to be cumbersome and may not be worn for long periods of time because of poor patient compliance and failure of the brace to maintain or prevent the progression of the kyphotic deformity. If the braces are worn 24 hours a day, seven days a week, this would lead to an inevitable atrophy of the paraspinous musculature, and increase susceptibility to fracture due to the loss in nutrition to the spine and vertebral column because of the degree of immobilization. Rigid braces, such as the TLSO, could lead to atrophy also of the thoracic cavity which could result in diminished respiratory tidal volume, as well as decrease tone of the abdominal musculature and thoracolumbar musculature, as well as decreasing the thoracic and lumbar bone density which could lead to compression fractures, which could lead to back pain and/or instability.
As well as being used for treating the elderly, braces may also be used to accommodate young populations that may be at risk. Young people may be at risk due to, e.g., carrying heavy books to school, as well as for rapidly developing young women who have developed a postural kyphosis to minimize their enlargement of their breasts, or in the male population in which the thin or esthetic young male who is not physically developed and has poor posture, can use this orthosis to improve their sagittal spinal contour.
It is estimated by some that 80% of the about 285 million people in the United States may injure their backs at some point in time necessitating them seeing a physician. It is the premise of some medical professionals that most disk disease and back pain may occur at a very early age from poor end plate nutrition to the disk, as well as from weakened paraspinous musculature and/or poor posture from and early age, e.g, from preteen all the way up to an adult. After 40, especially in the female population, the incidence of osteoporosis starts to become a significant factor, and this continues all the way up into the elderly. This is manifested also with a failure in the later population for exercising and performing good paraspinous muscle strengthening and the natural degenerative process of aging of the disks which leads to loss in disk height, decrease in disk hydration and increase in annular tears, as well as protrusions from the nucleus pulposus, as well as ligament instability leading to anterior listhesis, retrolisthesis, lateral listhesis or rotatory deformity.
As the population grows older, there is a loss in the disk space height over several levels which may lead to several inches lost in height. Therefore, a person who is six feet tall at age twenty, by the time they are eighty, could end up being five feet ten inches tall. The loss in height of the lumbar spine and thoracic vertebrae may result in a structural change.
As obesity has approached an epidemic proportion in the United States, some statistics show about two-thirds of all Americans are officially overweight, and among those that are overweight, about 50% are obese, and close to about 5% are morbidly obese. With the number of children becoming more and more inactive due to, e.g., TV, computer and video games and their access to junk food, this trend may continue to increase with secondary medical conditions, such as hypertension, diabetes, heart disease, which may continue to escalate costs for medical care. It is estimated at this point in time that approximately 117 billion dollars a year is spent on obesity-linked illnesses.
As a person becomes older it is typically more difficult for them to engage in cardiovascular exercise and exercise for the spine if this is something that the person has not started at an earlier age. Some patients, especially the elderly, may find it difficult to do much more than just walk. In some cases, the addition of one or two exercises in conjunction with the walking is not kept up after the patient has completed physical therapy.
Due to these trends, there is a need for an orthosis that may passively allow the spine and paraspinous muscles to work with little effort, thereby encouraging a patient to wear the orthosis so as to prevent poor posture, to prevent progressive kyphosis, to prevent juvenile round back syndrome, to decrease back pain and to assure appropriate spinal integrity as the patient ages.